The Business Challenge of Most Start-up RT Devices
Medical start-ups are on tight schedules imposed by their investors, especially new RT vendors. Inadequate management of the product or device development lifecycle and its associated risks can cause many problems with the investors – or even close the project. Many small new companies do not understand the complexities of medical device development or even medical software development.
When you break down the effort and time to develop software for a medically certifiable device, the actual “software writing and debugging” takes up approximately 30 per cent of the hours. In comparison, 70 per cent covers all the rest, for instance, following and documenting the quality assurance (QA) processes, strict testing and correcting, and preparing the system engineering documentation as demanded by the medical regulators.
“From our experience, the vast majority of start-ups don’t have much experience with quality-assured and project-based software development – especially for devices that have to be medically certified. Leo Cancer Care was one of the rare companies with an experienced management team that anticipated development hardships.
Software is usually the last thing to be integrated into the device, and it is only then that the problems with hardware devices and firmware manifest themselves fully. With the current difficulties with supply chains, any new or modified order for hardware can take a long time and jeopardise the project.”
Tine Musek, Key Account Manager at Cosylab
The Technical Solution for Leo Cancer Care
Many people are involved in the design and development of complex medical devices. Still, in the heavily regulated field of radiation therapy devices, it is systems engineers that have a very special role in development.
Good systems engineers help the customer define the optimal basic requirements, use-case requirements, specifications, system architecture, design, detailed designs, development, quality assurance, documentation, and testing regime. This way, the customer is guided down a series of interlinked decisions that transform the system into a medical-certifiable and market-viable product.
Leo Cancer Care knew their medical imaging and radiation therapy devices would have to use control systems on three levels. They could buy OncologyOne modules to fill the uppermost top layer. However, the latter would still have to be integrated to fit neatly into Leo Cancer Care’s specific systems structure setup and to communicate with the lower two layers.